Elutia Launches Study to Enhance Patient Outcomes with EluPro
Elutia Launches Innovative Clinical Study for EluPro
— Integration of clinical and patient-reported outcomes expected to further differentiate EluPro’s utility in cardiac implantable electronic device (CIED) procedures —
Elutia Inc. (NASDAQ: ELUT) has exciting news as they embark on a new clinical study aimed at gathering essential patient outcome data in everyday clinical settings. The study will focus on EluPro, a revolutionary antibiotic-eluting bioenvelope that has received FDA clearance for use with CIEDs and neurostimulators.
This innovative product is designed not just as a medical device but as a safeguard for patients, combining advanced antibiotics with a regenerative biomatrix that aids in healing and reduces complications. The very first patient was enrolled at UC San Diego Health, marking a significant step forward for Elutia's mission.
Commitment to Patient Well-being
“Every innovation we pursue is driven by a commitment to improving patient care,” shared Kimberly Mulligan, PhD, who serves as the Vice President and General Manager of Cardiovascular at Elutia. The thoughtful integration of trusted antibiotics with a soft biomatrix demonstrates Elutia’s dedication to enhancing patient safety during implantation procedures.
Through this clinical study, Elutia aims to demonstrate how EluPro can alter the landscape of patient experiences in CIED implantation. Collection of data on essential clinical and patient-reported outcomes will be at the forefront, focusing on key complications such as infections, lead dislodgment, device migration, and more.
Study Design and Goals
The clinical study is a multi-center, prospective, post-market endeavor, slated to enroll approximately 100 patients. These patients will be monitored over the course of 12 months following their device implantation, gathering crucial information that can refine medical practices.
With over 600,000 CIEDs implanted annually in the U.S., and complication rates soaring between 5-7%, the need for enhanced solutions is clear. EluPro stands out by addressing the often overlooked challenges with CIED implantation, potentially lowering rates of infection and other complications.
Market Potential and Product Differentiation
The CIED protection market is substantial, currently valued at around $600 million in the U.S. EluPro's unique formulation, incorporating the antibiotics rifampin and minocycline, combines with a soft biomatrix that not only protects the implant but also promotes healing post-operation. This innovation positions Elutia as a frontrunner in enhancing patient safety and improving health outcomes in cardiac procedures.
Unlike other products on the market, EluPro provides a solution that does not merely exist but is actively designed to mitigate risks associated with traditional devices. Its application across various major CIED brands speaks to its versatile nature, appealing to a broad spectrum of patients and healthcare providers alike.
About Elutia
Elutia is focused on the development and commercialization of advanced drug-eluting biomatrix products. Their mission aims at improving the compatibility between medical devices and the patients in need of them, reinforcing the notion that patient care can be elevated through innovation. With a commitment to humanizing medicine, Elutia endeavors to ensure patients can thrive alongside advanced medical technology.
Frequently Asked Questions
What is the purpose of the EluPro clinical study?
The study aims to collect patient outcome data in real-world clinical settings to evaluate the effectiveness of EluPro in CIED procedures.
How does EluPro enhance CIED procedures?
EluPro combines antibiotics with a soft biomatrix to reduce complications, promote healing, and improve patient outcomes during and after implantation.
What complications are monitored in the study?
The study monitors complications such as infection, lead dislodgment, device migration, and other implant site issues following CIED implantation.
How many patients will be involved in the study?
The study plans to enroll approximately 100 patients who will be followed for a period of 12 months after the implantation of their devices.
What is Elutia's overall mission?
Elutia strives to develop innovative solutions that enhance patient care and improve the compatibility of medical devices, making it a cornerstone of their business approach.
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